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UK – BioNTech/Pfizer v. CureVac – Split poly(A) tail mRNA patents invalid for insufficiency and obviousness

23 Oct 2024

Kate O’Sullivan

Bristows

Split poly(A) tail mRNA patents invalid for insufficiency and obviousness

On 8 October 2024, Mr Justice Meade handed down judgment in BioNTech SE and Pfizer Inc., (together, BioNTech/Pfizer) v CureVac SE. Meade J found CureVac’s patents, which concerned split poly(A) tails in mRNA, invalid for obviousness and insufficiency due to (i) lack of plausibility and (ii) because the purported technical effect does not in fact exist over substantially the whole scope of the claims. BioNTech/Pfizer’s added matter attack failed and is discussed only very briefly below.

BioNTech/Pfizer, the developer and supplier of the Comirnaty COVID-19 mRNA vaccines, issued proceedings seeking to revoke three patents owned by CureVac: (1) EP (UK) 1 865 122 (EP 122); (2) EP 3 (UK) 708 668 (EP 668); and (3) EP (UK) 4 023 755 (EP 755). Infringement was not disputed if the patents were held to be valid. Issues pertaining to the plausibility of EP 122 were adjourned so the
trial was limited to the revocation of EP 668 and EP 755. Both EP 668 and EP 755 (collectively, the Patents) concern mRNA molecules comprising split poly(A) tails, which were said to improve protein expression, use of said mRNAs as vaccines and intramuscular administration of said mRNAs. The priority date was 12 December 2014.

The entire contribution can be read here.

The judgment can be read here.